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Multiple Sclerosis

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Sponsored by Biogen

About this trial

Last updated 2 years ago

Study ID

272MS401

Status

Not yet recruiting

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
All
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

What are the Participation Requirements?

Key Inclusion Criteria:

- Participant must have a diagnosis of MS

- Documentation that the participant was one of the following:

1. exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e.,
conception date) up through any time during pregnancy. (If exact exposure dates
are unknown, the reporter must be able to specify or estimate trimester of
exposure).

2. unexposed to any DMT during pregnancy, defined as having never received DMT
therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the
first day of their LMP (i.e., conception date); or discontinued a non
Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after
the first day of their LMP (i.e., conception date)

- Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or
live birth)

Key Exclusion Criteria:

- None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply